W L Gore and Associates has announced the first implant of the Gore Excluder conformable abdominal aortic aneurysm endoprosthesis in the USA. The procedure took place on 19 December 2017 at Maimonides Medical Center in New York by Robert Rhee, chief of Vascular and Endovascular Surgery, and national principal investigator.
This endovascular aneurysm repair (EVAR) device, which is the first to feature angulation control, is part of an investigational clinical study approved by the US FDA. The clinical study will assess the safety and effectiveness of the device in treating infrarenal abdominal aortic aneurysms in patients with challenging anatomy. The clinical study consists of two sub-studies, each assessing the device for a different range of patient anatomies. The implantation by Rhee is part of the short neck substudy to assess the device in aortic neck angles of 0 to 60 degrees and aortic neck lengths of 10mm or greater. The high neck angulation substudy will evaluate proximal aortic neck angles of 61 to 90 degrees and aortic neck lengths of 10mm or greater.
“Patients with extreme proximal neck anatomies often do not qualify for EVAR. Regardless of device flexibility, current delivery systems make it difficult to achieve conformability during deployment,” said Rhee. “The angulation control in the new delivery system for the Gore Excluder conformable endoprosthesis device is intended to allow physicians a greater level of control to angle or bend the device to achieve orthogonal placement to the aortic blood flow lumen.”
The Gore Excluder conformable AAA device debuts the Active Control System into the abdominal aorta. This delivery system includes angulation control, giving physicians the option to angle or bend the device to achieve orthogonal placement to the aortic blood flow lumen and to maximise the conformability and seal of the device. It also offers the ability to reposition the device if needed after initial deployment to achieve optimal device placement.